Atherosclerotic Cardiovascular Disease

• FDA approval · 2020-04-07
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical's supplemental application for ROSUVASTATIN CALCIUM, a generic rosuvastatin calcium product, under approved …

• FDA approval · 2020-04-07
  FDA Approved: ROSUVASTATIN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for rosuvastatin from Camber Pharmaceuticals, a generic rosuvastatin product under an ANDA.

• FDA approval · 2020-03-12
  FDA Approved: ROSUVASTATIN — Supplemental Application (Accord Healthcare Inc.)

  FDA approved the supplemental application for rosuvastatin from Accord Healthcare Inc., extending approval for the generic rosuvastatin prod…

• FDA approval · 2020-03-10
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Cadila Pharmaceuticals Limited)

  FDA approved the supplemental application for Rosuvastatin Calcium submitted by Cadila Pharmaceuticals Limited.

• FDA approval · 2020-03-09
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Rosuvastatin Calcium from Torrent Pharmaceuticals Limited, expanding regulatory approval for thi…

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• FDA approval · 2020-03-09
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Glenmark Pharmaceutials Inc., USA)

  FDA approved Glenmark's supplemental application for rosuvastatin calcium, authorizing a generic rosuvastatin calcium product and expanding …

• FDA approval · 2020-03-09
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approves Westminster Pharmaceuticals' supplemental application for rosuvastatin calcium, confirming this rosuvastatin salt as an approve…

• FDA approval · 2020-03-09
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Rosuvastatin Calcium from Rising Pharma Holdings, Inc., enabling this rosuvastatin calcium g…

• FDA approval · 2020-02-26
  FDA Approved: NEXLIZET — Original Application (Esperion Therapeutics, Inc.)

  The FDA approved Nexlizet, a fixed-dose combination of bempedoic acid and ezetimibe, for adults with primary hyperlipidemia (including heter…

• FDA approval · 2020-02-21
  FDA Approved: NEXLETOL — Original Application (Esperion Therapeutics, Inc.)

  FDA approved Nexletol (bempedoic acid) as an original application for adults with heterozygous familial hypercholesterolemia or established …

• FDA approval · 2020-02-21
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for Rosuvastatin Calcium from Quallent Pharmaceuticals Health LLC, establishing a generic rosuvastat…

• FDA approval · 2020-01-29
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Dr.Reddys Laboratories Inc)

  The FDA approved a supplemental application for the generic fixed-dose combination ezetimibe and simvastatin by Dr. Reddy's Laboratories. Th…

• FDA approval · 2020-01-29
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for the ezetimibe and simvastatin fixed-dose combination developed by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2020-01-29
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for the ezetimibe and simvastatin combination product from Ascend Laboratories LLC.

• FDA approval · 2020-01-24
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's supplemental application for a generic ezetimibe and simvastatin combination product, expanding access to this lipid…

• FDA approval · 2019-11-04
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Zhejiang Yongtai Pharmaceutical Co., Ltd.)

  FDA approves rosuvastatin calcium as a generic drug (Original Application) by Zhejiang Yongtai Pharmaceutical Co., Ltd.

• FDA approval · 2019-10-25
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Novadoz Pharmaceuticals LLC)

  The FDA approved a supplemental application for atorvastatin calcium from Novadoz Pharmaceuticals LLC, authorizing its continued availabilit…

• FDA approval · 2019-10-22
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for atorvastatin calcium from Dr. Reddy's Laboratories Limited under an ANDA to enable continued mar…

• FDA approval · 2019-10-22
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for atorvastatin calcium from Dr. Reddy's Laboratories Limited, allowing the generic product to be m…

• FDA approval · 2019-10-21
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Cipla USA Inc.,)

  The FDA approved Cipla USA Inc.'s Supplemental Application for atorvastatin calcium, making a generic atorvastatin calcium product an approv…

• FDA approval · 2019-10-18
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for ATORVASTATIN CALCIUM submitted by Zydus Lifesciences Limited (ANDA 206536).

• FDA approval · 2019-10-16
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for atorvastatin calcium, a generic statin used to treat high cholesterol, unde…

• FDA approval · 2019-10-11
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' supplemental application to market atorvastatin calcium as a generic version of atorvastatin.

• FDA approval · 2019-09-26
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for the ezetimibe and simvastatin combination product from Ascend Laboratories, LLC (ANDA209222).

• FDA approval · 2019-08-22
  FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for simvastatin from Accord Healthcare, Inc., authorizing a change to the generic product.